<p>Sexual dysfunctions (SD) are common and debilitating side effects of antipsychotics. The current study analyzes the occurrence of antipsychotic-related SD using data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). FAERS was queried for sexual dysfunction adverse events (encoded by 35 different MedDRA preferred terms) secondary to amisulpride, aripiprazole, chlorprothixene, clozapine, haloperidol, loxapine, olanzapine, pipamperone, quetiapine, risperidone, and ziprasidone from 2000 to 2023. Disproportionality signal analysis was performed by calculating the reporting odds ratio (ROR) with its 95% confidence interval (CI). During the observation period, 9203 cases of SD were reported in association with the antipsychotic drug use. Men reported these dysfunctions more frequently (68.4% of all cases) than women. Ziprasidone had the highest ROR for sexual dysfunction in FAERS, at <InlineEquation ID="IEq1"> <InlineMediaObject> <ImageObject Color="BlackWhite" FileRef="210_2024_3763_Article_IEq1.gif" Format="GIF" Height="19" Rendition="HTML" Resolution="72" Type="Linedraw" Width="203" /> </InlineMediaObject> <EquationSource Format="TEX">$84.86; 95\%\,CI\,(77.50,\,92.94))$</EquationSource> <EquationSource Format="MATHML"><math> <mrow> <mn>84.86</mn> <mo>;</mo> <mn>95</mn> <mo>%</mo> <mspace width="0.166667em" /> <mi>C</mi> <mi>I</mi> <mspace width="0.166667em" /> <mo stretchy="false">(</mo> <mn>77.50</mn> <mo>,</mo> <mspace width="0.166667em" /> <mn>92.94</mn> <mo stretchy="false">)</mo> <mo stretchy="false">)</mo> </mrow> </math></EquationSource> </InlineEquation>, followed by aripirazole for sexual dysfunction <InlineEquation ID="IEq2"> <InlineMediaObject> <ImageObject Color="BlackWhite" FileRef="210_2024_3763_Article_IEq2.gif" Format="GIF" Height="19" Rendition="HTML" Resolution="72" Type="Linedraw" Width="271" /> </InlineMediaObject> <EquationSource Format="TEX">$(ROR= 34.17; 95\%\,CI\,(32.06,\,36.43))$</EquationSource> <EquationSource Format="MATHML"><math> <mrow> <mo stretchy="false">(</mo> <mi>R</mi> <mi>O</mi> <mi>R</mi> <mo>=</mo> <mn>34.17</mn> <mo>;</mo> <mn>95</mn> <mo>%</mo> <mspace width="0.166667em" /> <mi>C</mi> <mi>I</mi> <mspace width="0.166667em" /> <mo stretchy="false">(</mo> <mn>32.06</mn> <mo>,</mo> <mspace width="0.166667em" /> <mn>36.43</mn> <mo stretchy="false">)</mo> <mo stretchy="false">)</mo> </mrow> </math></EquationSource> </InlineEquation>. In general, aripiprazole, olanzapine, risperidone, ziprasidone, and quetiapine had higher risk signals across multiple adverse events (AEs), whereas chlorprothixene, loxapine, and amisulpride showed lower risk signals. The pathogenesis of SD does not appear to be limited to specific pathomechanisms and therefore not to specific substances. The differing report distributions by sex and the impact of polypharmacy on the symptoms warrant further investigations.</p>

Sexual dysfunctions associated with antipsychotic drug intake: a retrospective analysis of the FDA adverse events reporting system (FAERS)

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发表日期：

2025年1月11日

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Johanna Engel,
Lamin Jeridi,
Lilly Auerbach,
Oliver Zolk,
Timo Greiner,
Martin Heinze,
Pichit Buspavanich,
Michael Schneider

摘要

Sexual dysfunctions (SD) are common and debilitating side effects of antipsychotics. The current study analyzes the occurrence of antipsychotic-related SD using data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). FAERS was queried for sexual dysfunction adverse events (encoded by 35 different MedDRA preferred terms) secondary to amisulpride, aripiprazole, chlorprothixene, clozapine, haloperidol, loxapine, olanzapine, pipamperone, quetiapine, risperidone, and ziprasidone from 2000 to 2023. Disproportionality signal analysis was performed by calculating the reporting odds ratio (ROR) with its 95% confidence interval (CI). During the observation period, 9203 cases of SD were reported in association with the antipsychotic drug use. Men reported these dysfunctions more frequently (68.4% of all cases) than women. Ziprasidone had the highest ROR for sexual dysfunction in FAERS, at $84.86; 95\%\,CI\,(77.50,\,92.94))$ $84.86; 95 % C I (77.50, 92.94))$ , followed by aripirazole for sexual dysfunction $(ROR= 34.17; 95\%\,CI\,(32.06,\,36.43))$ $(R O R = 34.17; 95 % C I (32.06, 36.43))$ . In general, aripiprazole, olanzapine, risperidone, ziprasidone, and quetiapine had higher risk signals across multiple adverse events (AEs), whereas chlorprothixene, loxapine, and amisulpride showed lower risk signals. The pathogenesis of SD does not appear to be limited to specific pathomechanisms and therefore not to specific substances. The differing report distributions by sex and the impact of polypharmacy on the symptoms warrant further investigations.